immunogenicity and safety study of glaxosmithkline (gsk) biologicals' influenza vaccine, fluarix®/influsplit ssw® (2013/2014 season), in adults 18 years of age and older

Conditions: Influenza

Summary: the purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, fluarix/influsplit ssw 2013/2014, containing the three vaccine influenza strains (two a strains and one b strain) for the 2013/2014 season.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol. * a male or female aged 18 years or above at the time of vaccination. * written informed consent obtained from the subject. * healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study. * female subjects of non-childbearing potential may be enrolled in the study. * non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination. exclusion criteria: * participation in previous year's fluarix registration study (116663). * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. inhaled and topical steroids are allowed. * any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. * administration of an influenza vaccine within the twelve months preceding the study vaccination. * receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period. * clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. * acute disease and/or fever at the time of enrollment. * fever is defined as temperature ≥ 37.5°c/99.5°f on oral, axillary or tympanic setting, or ≥ 38.0°c/100.4°f on rectal setting. the preferred route for recording temperature in this study will be axillary. * subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious. * history of chronic alcohol consumption and/or drug abuse. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of guillain-barré syndrome. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex. * anaphylaxis following the administration of vaccine(s). * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.

Keywords: elderly influenza safety adults immunogenicity